WHA

AMTAGVI (lifileucel)

Office-Administration – intravenous (IV) infusion

Diagnosis considered for coverage:

Melanoma: Indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

Coverage Criteria:

For diagnosis of melanoma:

  • Diagnosis of melanoma; AND
  • Disease is one of the following: 
    • Unresectable 
    • Metastatic; AND
  • Previous treatment with a programmed cell death protein-1 (PD-1) blocking antibody (e.g., Opdivo, Keytruda); AND
  • If cancer is BRAF V600 mutation positive, one of the following: 
    • Previous treatment with a BRAF inhibitor alone (e.g., Zelboraf, Tafinlar), OR
    • Previous treatment with combination of a BRAF inhibitor and MEK inhibitor (e.g., Zelboraf/Cotellic, Tafinlar/Mekinist, Braftovi/Mektovi); AND
  • Prescribed by an oncologist at an authorized treatment center; AND
  • Patient has never received Amtagvi treatment in their lifetime
Coverage Duration:
  • Amtagvi is for one-time, single dose intravenous use only.
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information: 
  • Amtagvi (lifileucel) is the first T-cell immunotherapy for solid tumors, which utilizes patient’s own tumor infiltrating lymphocytes (TILs). 
  • Tumor infiltrating lymphocytes (TILs) = utilizes patient’s natural, tumor-specific T cells
  • Amtagvi (lifileucel) is a tumor - derived autologous T cell immunotherapy comprised of a suspension of tumor-derived T-cells for intravenous infusion. 
  • The manufacturing process for Amtagvi involves the removal of the tumor to obtain a sample for the amplification of TILs (tumor-infiltrating lymphocytes) cells in a culture. It typically takes about 34 days from the moment the manufacturing center receives tumor tissue until Amtagvi is prepared for shipment back to the healthcare provider. 
  • Before administration of Amtagvi, the patient undergoes non-myeloablative lymphodepletion (chemotherapy) regimen consisting of cyclophosphamide, mesna, and fludarabine. 
  • Following lymphodepletion, Amtagvi is administered as a one-time infusion, followed by up to six doses of intravenous IL-2 (aldesleukin), to support cell expansion in vivo. 
  • It is estimated that patients receiving Amtagvi will be hospitalized for at least 3 days to complete the Amtagvi and IL-2 administration. 
  • Amtagvi is administered at authorized treatment centers (ATCs), primarily in dense urban areas throughout the United States. These are centers selected based on patient volume, NCCN status, relationships with key opinion leaders, experience with existing cell therapy/bone marrow transplant, inpatient capacity, and whether they were involved in the Amtagvi clinical trials. 
     
Policy Updates:
  • 09/01/2024 – New policy for Amtagvi approved by WHA P&T Committee. (P&T, 08/20/2024)
References:
  1. Amtagvi Prescribing Information. Iovance Biotherapeutics Manufacturing LLC. Philadelphia, PA. February 2024. 
  2. ClinicalTrials.gov. Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma (LN-144). Available at: https://www.clinicaltrials.gov/study/NCT02360579?cond=NCT02360579&rank=1. Accessed March 6, 2024.  
  3. Proietti, I., Skroza, N., Michelini, S., et al. BRAF Inhibitors: Molecular Targeting and Imunomodulatory Actions. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7408709/#:~:text=The%20BRAF%20inhibitors%20vemurafenib%2C%20dabrafenib,and%20survival%20of%20melanoma%20cells. Accessed March 7, 2024. 
  4. Subbiah, V., Baik, C., Kirkwood, J. Clinical Development of BRAF plus MEK Inhibitor Combinations. Available at: https://www.cell.com/trends/cancer/fulltext/S2405-8033%2820%2930164-3. Accessed March 7, 2024. 
  5. Chesney, J., Lewis, K., Kluger, H., et al. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. Available at: https://jitc.bmj.com/content/jitc/10/12/e005755.full.pdf. Accessed March 7, 2024. 
  6. IPD Analytics - Amtagvi (lifileucel). Available at: file:///C:/Users/kdekhtaw/Downloads/IPD%20Analytics_RxInsights_New%20Drug%20Review_Amtagvi_02%202024%20(1).pdf. Accessed March 7, 2024. 
  7. Amtagvi.com. Available at https://amtagvi.com. Accessed March 7, 2024.  
  8. Clinical Consult April 11, 2024 with an oncologist.

Last review date: September 1, 2024